Safety and immunogenicity study of GSK Biologicals' malaria vaccine 257049, when incorporated into an EPI regimen.

• Conditions: Primary immunization against Plasmodium falciparum malaria in healthy male and female infants aged 6 to 10 weeks at first vaccine dose, if eligible according to inclusion and exclusion criteria.; Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

• Registration Number: EUCTR2012-005695-34-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-17
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 511

Inclusion Criteria

-A male or female infant between 6 and 10 weeks of age at the time of first vaccination.
-Signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
-Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.
-Subjects who have received one previous dose of OPV and BCG.
-Subjects who are born after a normal gestation period (between 36 and 42 weeks).

Are the trial subjects under 18? yes
Number of subjects for this age range: 511
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Acute disease at the time of enrolment.
-Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
-Laboratory screening tests out of range, specifically: ALT and creatinine above acceptable limit; Hemoglobin, Platelet count and Total white cell count below acceptable limit.
-Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Hemophilus influenzae type b or hepatitis B vaccines.
-BCG administration within one week of proposed administration of a study vaccine.
-OPV administration within four weeks of proposed administra-tion of a study vaccine.
-Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
-Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
-Administration of immunoglobulins, blood transfusions or other blood products since birth to the first dose of study vaccine or planned administration during the study period.
-Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
-Simultaneous participation in any other clinical trial.
-Twins (to avoid misidentification).
-Maternal death.
-History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
-Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified